Advanced or Metastatic Soft Tissue Sarcoma MedDRA version: 18.0 Level: HLT Classification code 10041298 Term: Soft tissue sarcomas histology unspecified System Organ Class: 100000004864
Conditions
Interventions
Product Name: Olaratumab
Product Code: LY3012207
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Olaratumab
CAS Number: 1024603-93-7
Current Sponsor code: LY3012207
Other descriptive n
Sponsors
Lilly S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 years or older at study entry - Histologically confirmed diagnosis of locally advanced unresectable or metastatic STS not amenable to curative treatment with surgery or radiotherapy. Grade 1 liposarcoma are elegible if there is histological or radiographic evidence of evolution to more aggresive disease. (excludes GIST & Kaposi) - Measurable or nonmeasurable but evaluable disease by RECIST 1.1 - ECOG 0-1 - May have had any number of prior systemic therapies for advanced/metastatic disease, however may not have received any previous treatment with anthracyclines. All previous therapies must have been completed ? 4 weeks (28 days) prior to randomization. - Consent to provide adequate archived FFPE tumor tissue or be subject to a pre-treatment biopsy of primary or metastatic tumor tissue for research LVEF ?= 50% - Life expectancy, in opinion of the investigator, is at least 3 months - Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: - Diagnosed with GIST or Kaposi sarcoma - Active CNS or brain metastasis at randomization - The patient has received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones; the patient has received prior olaratumab treatment. - Prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation - Electively planned or required major surgery during the study - Uncontrolled intercurrent illness including, but not limited to, an ongoing/active infection requiring parenteral antibiotics, symptomatic congestive heart failure (CHF), left ventricular dysfunction (LVEF), severe myocardial insufficiency, cardiac arrhythmia, cardiomyopathy, or a psychiatric illness/social situation that would limit compliance with study requirements - Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction - Resting heart rate of >= 100 bpm - QTc interval >= 450 msec and >= 470 msec for males and females, respectively, on screening ECG - Current hematologic malignancies - Pregnant or breastfeeding - Active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare doxorubicin plus olaratumab versus doxorubicin plus placebo with respect to OS in 2 populations: 1) Patients with advanced or metastatic soft tissue sarcoma (STS) not amenable to treatment with surgery or radiotherapy with curative intent. 2) Patients with advanced or metastatic leiomyosarcoma (LMS) not amenable to treatment with surfery or radiotherapy with curative intent.;Secondary Objective: The secondary objectives of the study are to compare doxorubicin plus olaratumab versus doxorubicin plus placebo with respect to: ? Progression-free survival (PFS) ? Objective response rate (ORR) (complete response [CR] + partial response [PR]) ? Disease control rate (DCR; CR + PR + stable disease [SD]) ? Duration of response (DoR) ? Duration of disease control ? Patient-reported outcomes (PROs): Pain, Health-related Quality of Life (HRQoL), and health status ? Safety and tolerability ? Pharmacokinetics (PK) and immunogenicity;Primary end point(s): Overall suvival;Timepoint(s) of evaluation of this end point: time from randomization to death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? PFS ? ORR ? DCR - Time to first worsening of the mBPI-sf (Brief Pain Inventory Short Form Modified) "worst pain" score ? Duration of response ? Duration of disease control ? Safety and tolerability ? PK and immunogenicity;Timepoint(s) of evaluation of this end point: - PFS is determined from the date of randomization and the date on which disease progresses or the date on which the patient dies, from any cause, whichever is earlier. - Response rates (ORR=CR+PR/Randomized subjects) (DCR=CR+PR+SD/Randomized siubejcts) will be based on evaluations done every 6 weeks until radiographic documentation of progression. - DoR and duration of disease control is measured from the time measurement criteria are first met for CR or PR until the first date of objective progression is observed . - PRO: Day 1 of every cycle, Short-Term Follow-Up and Long-Term Follow-Up - Safety and tolerability: On study treatment, Short-Term Follow-Up and Long-Term Follow-Up - PK and immunogenicity: At various time points according to the protocol and in the event of IRR | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Democratic People's Republic of, Mexico, Netherlands, Poland, Russian Federation, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactMaria Pilar López
Lilly S.A.
Outcome results
None listed